Liquid Biopsy Solution Enables Non-Invasive Sample Collection and Direct Cell-Free DNA Stabilization from Urine
By LabMedica International staff writers Posted on 26 Sep 2024 |

Urine cell-free DNA (cfDNA) presents significant potential for research and future clinical applications. It facilitates the measurement and analysis of cfDNA fragments, detection of genetic alterations, assessment of methylation status, and generation of genomic data that may not be obtainable from blood samples. However, analyzing urine cfDNA has posed challenges, as cfDNA degrades quickly after collection, potentially releasing contaminating genomic DNA. Now, an innovative solution enables non-invasive sample collection and immediate stabilization of cfDNA in urine, making standardized urine sampling practical for clinical use.
PreAnalytiX GmbH (Hombrechtikon, Switzerland), a joint venture between QIAGEN N.V. (Venlo, The Netherlands) and BD (Becton, Dickinson and Company, Franklin Lakes, NJ, USA), has launched the PAXgene Urine Liquid Biopsy Set. This set enables the reliable analysis of cfDNA from urine using molecular testing technologies such as qPCR, digital PCR, and next-generation sequencing (NGS). The PAXgene Urine Liquid Biopsy Set tackles the challenge of accessing cfDNA in urine by integrating a preservation solution that stabilizes cfDNA at the point of collection. It is the first set to offer a validated, standardized, and comprehensive preanalytical workflow, making urine cfDNA analysis more accessible for research purposes.
The PAXgene Urine Liquid Biopsy Set marks a significant improvement in sample quality, standardization, and ease of use for researchers handling urine samples. It features a closed system for urine collection and cfDNA stabilization, offering flexibility for sample shipment and storage under various conditions. Additionally, it integrates seamlessly into established workflows and is compatible with QIAGEN's industry-leading sample preparation products. Developed in line with Europe’s latest CEN/TS standards for the preanalytical handling of urine cfDNA, the set provides an optimized and standardized workflow.
Urine liquid biopsy has immense potential to aid researchers in detecting minimal residual disease, monitoring treatment responses, and identifying therapeutic targets, complementing blood plasma analysis for a more comprehensive understanding. However, unlike blood samples, there has been a lack of well-established technical solutions for the collection, storage, transport, and processing of urine samples—until now. The PAXgene Urine Liquid Biopsy Set bridges this gap. Commercialized by QIAGEN, the new set complements the company’s broader portfolio of liquid biopsy solutions, which cover various analytes (circulating cell-free nucleic acids, tumor cells, exosomes) and molecular detection technologies (NGS, qPCR, digital PCR), empowering researchers and clinicians to harness the full potential of liquid biopsy across diverse applications.
“With the innovative PAXgene Urine Liquid Biopsy Set, we are excited to address a pressing market need for a urine collection, stabilization, transport and storage device that is integrated into a complete preanalytical workflow for the development of cfDNA-based tests,” said Dr. Uwe Oelmueller, PreAnalytiX Management Committee Co-Chair and Head of MDx Development Sample Technologies at QIAGEN. “Liquid biopsies have huge potential, but accurate results are highly dependent on the workflow. As a result, the stabilization of analyte profiles in samples is critical to ensure that test results are reliable and reproducible."
Related Links:
PreAnalytiX GmbH
QIAGEN N.V.
BD
Latest Pathology News
- AI-Based Model Predicts Kidney Cancer Therapy Response
- Sensitive and Specific DUB Enzyme Assay Kits Require Minimal Setup Without Substrate Preparation
- World’s First AI Model for Thyroid Cancer Diagnosis Achieves Over 90% Accuracy
- Breakthrough Diagnostic Approach to Significantly Improve TB Detection
- Rapid, Ultra-Sensitive, PCR-Free Detection Method Makes Genetic Analysis More Accessible
- Spit Test More Accurate at Identifying Future Prostate Cancer Risk
- DNA Nanotechnology Boosts Sensitivity of Test Strips
- Novel UV and Machine Learning-Aided Method Detects Microbial Contamination in Cell Cultures
- New Error-Corrected Method to Help Detect Cancer from Blood Samples Alone
- "Metal Detector" Algorithm Hunts Down Vulnerable Tumors
- Novel Technique Uses ‘Sugar’ Signatures to Identify and Classify Pancreatic Cancer Cell Subtypes
- Advanced Imaging Reveals Mechanisms Causing Autoimmune Disease
- AI Model Effectively Predicts Patient Outcomes in Common Lung Cancer Type
- AI Model Predicts Patient Response to Bladder Cancer Treatment
- New Laser-Based Method to Accelerate Cancer Diagnosis
- New AI Model Predicts Gene Variants’ Effects on Specific Diseases
Channels
Clinical Chemistry
view channel
Mass Spectrometry-Based Monitoring Technique to Predict and Identify Early Myeloma Relapse
Myeloma, a type of cancer that affects the bone marrow, is currently incurable, though many patients can live for over 10 years after diagnosis. However, around 1 in 5 individuals with myeloma have a high-risk... Read more
‘Brilliantly Luminous’ Nanoscale Chemical Tool to Improve Disease Detection
Thousands of commercially available glowing molecules known as fluorophores are commonly used in medical imaging, disease detection, biomarker tagging, and chemical analysis. They are also integral in... Read more
Low-Cost Portable Screening Test to Transform Kidney Disease Detection
Millions of individuals suffer from kidney disease, which often remains undiagnosed until it has reached a critical stage. This silent epidemic not only diminishes the quality of life for those affected... Read more
New Method Uses Pulsed Infrared Light to Find Cancer's 'Fingerprints' In Blood Plasma
Cancer diagnoses have traditionally relied on invasive or time-consuming procedures like tissue biopsies. Now, new research published in ACS Central Science introduces a method that utilizes pulsed infrared... Read moreMolecular Diagnostics
view channel
New Genetic Tool Analyzes Umbilical Cord Blood to Predict Future Disease
Children are experiencing metabolic problems at increasingly younger ages, placing them at higher risk for serious health issues later in life. There is a growing need to identify this risk from birth... Read more
Spinal Fluid Biomarker for Parkinson’s Disease Offers Early and Accurate Diagnosis
Parkinson’s disease is a neurodegenerative condition typically diagnosed at an advanced stage based on clinical symptoms, primarily motor disorders. However, by this time, the brain has already undergone... Read moreHematology
view channel
New Scoring System Predicts Risk of Developing Cancer from Common Blood Disorder
Clonal cytopenia of undetermined significance (CCUS) is a blood disorder commonly found in older adults, characterized by mutations in blood cells and a low blood count, but without any obvious cause or... Read more
Non-Invasive Prenatal Test for Fetal RhD Status Demonstrates 100% Accuracy
In the United States, approximately 15% of pregnant individuals are RhD-negative. However, in about 40% of these cases, the fetus is also RhD-negative, making the administration of RhoGAM unnecessary.... Read moreImmunology
view channel
Stem Cell Test Predicts Treatment Outcome for Patients with Platinum-Resistant Ovarian Cancer
Epithelial ovarian cancer frequently responds to chemotherapy initially, but eventually, the tumor develops resistance to the therapy, leading to regrowth. This resistance is partially due to the activation... Read more
Machine Learning-Enabled Blood Test Predicts Immunotherapy Response in Lymphoma Patients
Chimeric antigen receptor (CAR) T-cell therapy has emerged as one of the most promising recent developments in the treatment of blood cancers. However, over half of non-Hodgkin lymphoma (NHL) patients... Read moreMicrobiology
view channel
New Test Diagnoses Bacterial Meningitis Quickly and Accurately
Bacterial meningitis is a potentially fatal condition, with one in six patients dying and half of the survivors experiencing lasting symptoms. Therefore, rapid diagnosis and treatment are critical.... Read more
Handheld Device Delivers Low-Cost TB Results in Less Than One Hour
Tuberculosis (TB) remains the deadliest infectious disease globally, affecting an estimated 10 million people annually. In 2021, about 4.2 million TB cases went undiagnosed or unreported, mainly due to... Read more
New AI-Based Method Improves Diagnosis of Drug-Resistant Infections
Drug-resistant infections, particularly those caused by deadly bacteria like tuberculosis and staphylococcus, are rapidly emerging as a global health emergency. These infections are more difficult to treat,... Read more
Breakthrough Diagnostic Technology Identifies Bacterial Infections with Almost 100% Accuracy within Three Hours
Rapid and precise identification of pathogenic microbes in patient samples is essential for the effective treatment of acute infectious diseases, such as sepsis. The fluorescence in situ hybridization... Read moreTechnology
view channel
Disposable Microchip Technology Could Selectively Detect HIV in Whole Blood Samples
As of the end of 2023, approximately 40 million people globally were living with HIV, and around 630,000 individuals died from AIDS-related illnesses that same year. Despite a substantial decline in deaths... Read more
Pain-On-A-Chip Microfluidic Device Determines Types of Chronic Pain from Blood Samples
Chronic pain is a widespread condition that remains difficult to manage, and existing clinical methods for its treatment rely largely on self-reporting, which can be subjective and especially problematic... Read more
Innovative, Label-Free Ratiometric Fluorosensor Enables More Sensitive Viral RNA Detection
Viruses present a major global health risk, as demonstrated by recent pandemics, making early detection and identification essential for preventing new outbreaks. While traditional detection methods are... Read moreIndustry
view channel
Cepheid and Oxford Nanopore Technologies Partner on Advancing Automated Sequencing-Based Solutions
Cepheid (Sunnyvale, CA, USA), a leading molecular diagnostics company, and Oxford Nanopore Technologies (Oxford, UK), the company behind a new generation of sequencing-based molecular analysis technologies,... Read more
Grifols and Tecan’s IBL Collaborate on Advanced Biomarker Panels
Grifols (Barcelona, Spain), one of the world’s leading producers of plasma-derived medicines and innovative diagnostic solutions, is expanding its offer in clinical diagnostics through a strategic partnership... Read more